A Randomized Open-label Study of 400 mg Versus 800 mg of Imatinib Mesylate in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Using Molecular Endpoints.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants With Major Molecular Response (MMR) Rates at 12 Months
MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally).
12 months
No
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CSTI571K2301
NCT00124748
June 2005
November 2010
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Rocky Mountain Cancer Center | Denver, Colorado 80218 |
Cancer Center at Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
University of Minnesota | Minneapolis, Minnesota 55455 |
Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |
Integrated Community Oncology Network | Jacksonville Beach, Florida 32250 |
Duke University Medical Center | Durham, North Carolina 27710 |
Indiana Blood and Marrow Transplant | Beech Grove, Indiana 46107 |
UCLA Medical Center | Los Angeles, California 90095-7059 |
University of Kentucky | Lexington, Kentucky 40536-0098 |
Hematology and Oncology Specialists | New Orleans, Louisiana 70115 |
San Juan Oncology Associates | Farmington, New Mexico 87401 |
Cancer Center of the Carolinas | Greenville, South Carolina 29615 |
The Jones Clinic | Germantown, Tennessee 38138 |
Kaiser Permanente Northwest Region | Portland, Oregon 97227 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
University of South Alabama | Mobile, Alabama 36693 |
University of Miami | Berkeley, California 94704 |
Alta Bates Comprehsenive Cancer Center | Berkeley, California 94704 |
South Bay Oncology Hematology Partners | Campbell, California 95008 |
Osler Medical Inc. | Melbourne, Florida 32901 |
Advanced Medical Specialists | Miami, Florida 33176 |
Hematology-Oncology Associates, P.A. | Pensacola, Florida 32501 |
Indiana Blood and Marrow Institutw | Beech Grove, Indiana 46107 |
University of Iowa Hospitals & Clinic | Iowa City, Iowa 52242 |
University of Kentucky - C201 Clinic | Lexington, Kentucky 40536 |
Lousville Oncology, Clinical Research Program M-25 | Louisville, Kentucky 40202 |
Jayne S. Gurtler, MD, Laura A. Brinz, MD & Angelo Russo, MD | Metairie, Louisiana 70006 |
LSU Health Scine Center | Shreveport, Louisiana 71130 |
LSU Health Science Center | Shreveport, Louisiana 71103 |
St. Agnes Hospital | Baltimore, Maryland 21229 |
Great Lakes Cancer Institute | Lansing, Michigan 48910 |
U of Minnesota | Minneapolis, Minnesota 55455 |
Cancer Center of the Carolinas | Greenville, North Carolina 29615 |
University Hospitals of Cleveland, Case Comprehensive Cancer Center | Cleveland, Ohio 44106 |
Kaiser Permanente Northwest Region Oncology/Hemacology | Portland, Oregon 97227 |
University of Pittsburg, Hillman Cancer Center | Pittsburgh, Pennsylvania 15232 |
MUSC Hollings Cancer Center | Charleston, South Carolina 29425 |
UT Southwestern Harold C. Simmons Comprehensive Cancer Center | Dallas, Texas 75390 |
University of Texas / MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Virgina Cancer Center, UVA Division of Hematology & Oncology | Charlottesville, Virginia 22908 |